Quality Engineer QA (2 positions)

Jobinhalt

As Quality Engineer, you are responsible for guaranteeing quality by following up and ensuring that all operations at all levels are done according to the applied GMP quality systems at Prothya Biosolutions. In this way, you help ensure that the quality of the pharmaceutical products from Prothya Biosolutions fulfils the European and American GMP guidelines.

The Quality Engineer reports to the Supervisor QA.

Key responsibilities and result areas

1. You are responsible for guaranteeing quality by following up and ensuring that processes and activities are carried out according to the applicable cGMP quality standards:

• You assess batch records, events (deviations, OOS/OOL) and complaints.
• You monitor written documents such as procedures, protocols and reports concerning quality systems from other departments.
• You take care of the correction and authorisation of these procedures, protocols and reports.
• You are responsible for maintaining control of batch records and lab records.

2. You participate in different projects related to risk analyses, qualification and validation:

• You are responsible for performing risk analyses and determining corrective and preventive measures (CAPAs).
• You monitor changes via Change control.
• You monitor initial and routine validation and qualifications.
• You participate in or supervise quality-related projects.

3. You are responsible for informing, raising awareness and training Prothya Biosolutions employees:

• You contribute to guaranteeing the quality level and you work on continuous (quality) improvement.
• You are responsible for informing colleagues about quality, pharmaceutical legislation and rules.
• You are responsible for encouraging employees to respect the pharmaceutical rules.

Profile

• You have a Master’s degree (preferably in Chemistry, Industrial Pharmacy, Biotechnology, etc.) or equivalent through experience.
• You have at least 2 years of experience in a similar position in the pharmaceutical, medical device or biotech sector.
• Knowledge of quality systems is a requirement; experience with European and American GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is a bonus.
• You work efficiently with MS Office package; knowledge of SAP/TRACKWISE is an asset.
• You can communicate fluently in Dutch and/or French, and you have a good knowledge of English (both spoken and written).
• You are analytical and good at solving problems.
• You are results-oriented and decisive.
• You are customer-oriented, persuasive, communicative, and cooperative.
• You are stress-resistant.

Our Company

Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions’ mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya’s slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people.

We offer

Prothya Biosolutions BE is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.

In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year.

We also offer an attractive holiday system exceeding the legal holidays.

Furthermore, we value mutual respect and diversity is our strength.

For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.

Are you interested? Send your CV and covering letter.